HOFFMANN 5079-6-040Recalls & reported problems
Stryker GmbH · Connecting Rod Micro · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Stryker Hoffmann connecting rod is named in 40 adverse event reports, with no deaths or injuries; the reports mostly describe cracks in the rod, sometimes after cleaning, sterilization, reprocessing, or reuse. One open recall starting in July 2026 concerns potential cracking of Hoffmann II Carbon Connecting Rods after cleaning and sterilization. There were 40 reports in the last 12 months and none in the prior 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 21
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 04546540389909), received between May 28, 2026 and Aug 27, 2026 — classified as 21 malfunctions.
The most frequently reported specific device problem is “Crack” (21 reports).
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- Jul 1, 2026Open, Classified
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
Z-2828-2026 · Root cause: Device Design · FDA record ↗
Most reported problems
Device problems
- Crack21
Patient problems
- No Clinical Signs, Symptoms or Conditions21
Recent adverse event reports
The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 27, 2026Crack
It was reported that, cracks were seen on the product after inspection.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50478958 ↗MalfunctionAug 27, 2026Crack
It was reported that, cracks were seen on the product after inspection.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50478947 ↗MalfunctionAug 27, 2026Crack
It was reported that, cracks were seen on the product after inspection.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50478692 ↗MalfunctionAug 26, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50456982 ↗MalfunctionAug 24, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50418737 ↗MalfunctionAug 24, 2026Crack
Cracks identified in Hoffmann Micro carbon rods.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50418734 ↗MalfunctionAug 24, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50418717 ↗MalfunctionAug 24, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50410157 ↗MalfunctionAug 20, 2026Crack
It was reported that, there were cracks on the rods.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50347175 ↗MalfunctionAug 20, 2026Crack
It was reported that, there were cracks on the rods.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50347174 ↗MalfunctionMay 28, 2026Crack
AS REPORTED: "CARBON RODS SHOW VISIBLE CRACKS AFTER STERILIZATION/CLEANING (REPROCESSING)'.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25322155 ↗MalfunctionMay 28, 2026Crack
AS REPORTED: "CARBON RODS SHOW VISIBLE CRACKS AFTER STERILIZATION/CLEANING (REPROCESSING)".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25322143 ↗MalfunctionMay 28, 2026Crack
AS REPORTED: "CARBON RODS SHOW VISIBLE CRACKS AFTER STERILIZATION/CLEANING (REPROCESSING)".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25321949 ↗MalfunctionMay 28, 2026Crack
AS REPORTED: "CARBON RODS SHOW VISIBLE CRACKS AFTER STERILIZATION/CLEANING (REPROCESSING)".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25321927 ↗MalfunctionMay 28, 2026Crack
AS REPORTED: "CARBON RODS SHOW SMALL CRACKS AND SWELLING AFTER THE FIRST CLEANING/STERILIZATION CYCLE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25321716 ↗MalfunctionMay 28, 2026Crack
IT WAS REPORTED THAT THE REPLACEMENT DELIVERY OF THE CARBON RODS WERE RECEIVED. THEY WERE PROCESSED ONCE IN THE REPROCESSING/STERILIZATION UNIT FOR MEDIZINPRODUKTE (AEMP (AUFBEREITUNGSEINHEIT FOR MEDIZINPRODUKTE)), UNFORTUNATELY THE CARBON RODS BROKE AGAIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25321555 ↗MalfunctionMay 28, 2026Crack
IT WAS REPORTED THAT THE REPLACEMENT DELIVERY OF THE CARBON RODS WERE RECEIVED. THEY WERE PROCESSED ONCE IN THE REPROCESSING/STERILIZATION UNIT FOR MEDIZINPRODUKTE (AEMP (AUFBEREITUNGSEINHEIT FOR MEDIZINPRODUKTE)), UNFORTUNATELY THE CARBON RODS BROKE AGAIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25321537 ↗MalfunctionMay 28, 2026Crack
IT WAS REPORTED THAT THE REPLACEMENT DELIVERY OF THE CARBON RODS WERE RECEIVED. THEY WERE PROCESSED ONCE IN THE REPROCESSING/STERILIZATION UNIT FOR MEDIZINPRODUKTE (AEMP (AUFBEREITUNGSEINHEIT FOR MEDIZINPRODUKTE)), UNFORTUNATELY THE CARBON RODS BROKE AGAIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25320943 ↗MalfunctionMay 28, 2026Crack
IT WAS REPORTED THAT THE REPLACEMENT DELIVERY OF THE CARBON RODS WERE RECEIVED. THEY WERE PROCESSED ONCE IN THE REPROCESSING/STERILIZATION UNIT FOR MEDIZINPRODUKTE (AEMP (AUFBEREITUNGSEINHEIT FOR MEDIZINPRODUKTE)), UNFORTUNATELY THE CARBON RODS BROKE AGAIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25320923 ↗MalfunctionMay 28, 2026Crack
AS REPORTED: ''CARBON RODS SHOW SMALL CRACKS AND SWELLING AFTER THE FIRST CLEANING/STERILIZATION CYCLE.''
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25318334 ↗MalfunctionMay 28, 2026Crack
AS REPORTED: "CARBON RODS SHOW SMALL CRACKS AND SWELLING AFTER THE FIRST CLEANING/STERILIZATION CYCLE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25318330 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.